27th Feb 2007 07:34
Deltex Medical Group PLC27 February 2007 Deltex Medical Group plc Oesophageal Doppler Monitoring recommended for reimbursement coverage in USA 27 February 2007 Deltex Medical Group plc ('Deltex Medical' or the 'Company'),the UK's leading haemodynamic monitoring company, today announces thatoesophageal Doppler monitoring has been recommended for reimbursement coveragein the United States. The Deltex Medical CardioQ system is the most widely usedoesophageal Doppler monitor in the world. The Centers for Medicare & Medicaid Services (CMS), the government bodyresponsible for determining coverage for the reimbursement of medicaltechnologies in the USA, yesterday published a favourable draft decision memobased on an application originally submitted by Deltex Medical in mid-2006. Thisapplication sought to reverse an existing national non-coverage determinationthat oesophageal Doppler monitoring had no proven clinical benefit. Thisdetermination was made before Deltex Medical's CardioQ technology and theclinical evidence supporting its use was available. This pre-existingdetermination effectively precluded any reimbursement for the use of the CardioQin the USA. The draft decision memo is available for review at: www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=196 Under its due process CMS is obliged to publish the final decision memo not morethan sixty days after a thirty-day public consultation period that started 26February. Only after this period will the process of negotiating the level ofreimbursement begin that, when complete, will enable hospitals and physicians tomake formal reimbursement claims. If a technology is 'covered' it is possible for hospitals to receive a payment(reimbursement) that covers the costs associated with the purchase and use ofthat technology. In some cases coverage will also allow a physician to bepersonally reimbursed for the time and skill required to use a particulartechnology. While a positive coverage determination does not absolutelyguarantee that reimbursement will be granted or, if it is, that it will be at anadequate level, it is all but impossible for reimbursement to be granted withouta positive coverage determination being in place. Deltex Medical's chief executive, Andy Hill, commented: "This draft decision represents an important milestone in the development of ourUS business. Securing reimbursement for a new medical technology is the singlemost important step in establishing it as a standard of care in the world'slargest market for medical equipment. The decision was based on a CMS-commissioned Technology Assessment - anextensive, independently conducted analysis of the existing body of clinicaldata related to the use of oesophageal Doppler monitoring. All the datareviewed in the Technology Assessment was from clinical trials undertaken usingDeltex Medical's products. The assessment states that using the CardioQ 'duringsurgery effectively reduces total complications and length of hospital stay'." For further information, please contact:- Deltex Medical Group plc 01243 774 837Nigel Keen, Chairman [email protected] Hill, Chief Executive [email protected] Phillips, Finance Director [email protected] Gavin Anderson & Company 0207 554 1400Deborah Walter [email protected] Speed [email protected] Charles Stanley Securities 020 7149 6457Philip Davies [email protected] Notes for Editors Deltex Medical manufactures and markets the CardioQ monitor, which usesdisposable ultra-sound probes inserted into the oesophagus to determine theamount of blood being pumped around the body - 'circulating blood volume'.Reduced circulating blood volume is known as hypovolaemia, which leads toinsufficient oxygen being delivered to the organs. This causes medicalcomplications including peripheral and major organ failure which can lead todeath. Hypovolaemia, which is akin to severe dehydration, affects virtuallyevery patient having surgery because of the combined effects of pre-operativestarvation, the impact of the anaesthetic agents and trauma from the surgeryitself. Using fluids and drugs, guided by the CardioQ, to optimise the amount ofcirculating blood significantly reduces post-operative complications allowingpatients to make a faster, more complete recovery and return home earlier. The CardioQ incorporates the Company's proprietary software and a smalldiameter, easy-to-use, minimally invasive, disposable oesophageal probe that isused for transmitting and receiving an ultra-sound signal. By using thistechnology, the CardioQ provides clinicians with the ability to haemodynamicallyoptimise critically ill patients and those undergoing routine moderate to majorsurgery through the controlled administration of fluid and drugs. Haemodynamicoptimisation has been scientifically proven to improve the speed and quality ofpatient recovery and reduce hospital stay. There are already over 1,250 CardioQs currently in use in hospitals worldwideand distribution arrangements are in place in over 30 countries. In addition,there are currently more than 90 clinical publications on the use of the CardioQwhich have repeatedly:- • Validated the results of the Monitor against known standards for measuring cardiac output, demonstrating that the technology works • Proved that the CardioQ works in a wide range of surgical procedures • Demonstrated that the Company's technology provides significant health and economic benefits by helping to reduce post-operative complications and length of hospital stays by an average of 30 to 40 per cent for a wide range of patients. The SupraQ is an entirely non-invasive device which uses an ultrasound probeheld at the base of the patient's neck to track the flow of blood in the aorta;it presents the same data as the CardioQ in a similar format and is used fortaking snapshots or monitoring over short periods. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
Deltex Medical